National Institute on Alcohol Abuse and Alcoholism; Amended Notice of Meeting, 37234 [2024-09727]
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Federal Register / Vol. 89, No. 88 / Monday, May 6, 2024 / Notices
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Consideration of Enforcement
Policies for Tests During a Section 564
Declared Emergency.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This
guidance document is also available at
https://www.regulations.gov and https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents.
Persons unable to download an
electronic copy of ‘‘Consideration of
Enforcement Policies for Tests During a
Section 564 Declared Emergency’’ may
send an email request to CDRH-
III. Paperwork Reduction Act of 1995
While this guidance contains no new
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by OMB under the PRA (44
U.S.C. 3501–3521). The collections of
information in the following table have
been approved by OMB:
21 CFR part or guidance
Topic
807, subpart E .........................................................................
814, subparts A through E ......................................................
814, subpart H .........................................................................
812 ...........................................................................................
860, subpart D .........................................................................
800, 801, 809, and 830 ...........................................................
Premarket notification ..............................................................
Premarket approval .................................................................
Humanitarian Use Devices; Humanitarian Device Exemption
Investigational Device Exemption ...........................................
De Novo classification process ...............................................
Medical Device Labeling Regulations; Unique Device Identification.
Emergency Use Authorization .................................................
0910–0120
0910–0231
0910–0332
0910–0078
0910–0844
0910–0485
Medical Device Reporting .......................................................
CLIA Administrative Procedures; CLIA Waivers .....................
0910–0437
0910–0607
‘‘Emergency Use Authorization of Medical Products and Related Authorities’’.
803 ...........................................................................................
‘‘Administrative Procedures for CLIA Categorization’’ and
‘‘Recommendations: Clinical Laboratory Improvement
Amendments of 1988’’ (CLIA) Waiver Applications for
Manufacturers of In Vitro Diagnostic Devices’’.
Dated: April 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
Institutes of Health, 6700B Rockledge
Drive, Room 2118, Bethesda, MD 20892,
(301) 443–2861, marmillotp@
mail.nih.gov. Additionally, the meeting
end time on May 8, 2024, has changed
from 3:30 p.m. to 3:45 p.m. The meeting
on May 7, 2024, is partially closed to the
public in accordance with provisions set
forth in sections 552b(c)(4) and
552b(c)(6), title 5 U.S.C., as amended,
and the meeting on May 8, 2024, is open
to the public.
[FR Doc. 2024–08933 Filed 4–29–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Amended Notice of
Meeting
ddrumheller on DSK120RN23PROD with NOTICES1
Guidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number GUI00007009
and complete title to identify the
guidance you are requesting.
Notice is hereby given of a change in
the meeting of the National Advisory
Council on Alcohol Abuse and
Alcoholism, May 7, 2024, 10:00 a.m. to
May 8, 2024, 3:30 p.m., National
Institutes of Health, National Institute
on Alcohol Abuse and Alcoholism,
6700B Rockledge Drive, Conference
Rooms A, B, & C, Bethesda, MD 20817
which was published in the Federal
Register on April 9, 2024, FR Doc.
2024–07500, 89 FR 24846.
This notice is being amended to
replace the Contact Person from Ranga
V. Srinivas, Ph.D. to Philippe Marmillot,
Ph.D. Director, Office of Extramural
Activities, Office of Extramural
Activities, National Institute on Alcohol
Abuse and Alcoholism, National
VerDate Sep<11>2014
18:02 May 03, 2024
Jkt 262001
Dated: April 30, 2024.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–09727 Filed 5–3–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
OMB control No.
0910–0595
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RFA–NS–
24–021: HEAL Initiative: Individual
Differences in Human Pain Conditions.
Date: June 3–4, 2024.
Time: 8:30 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: North Bethesda Marriott Hotel &
Conference Center, Montgomery County
Conference Center Facility, 5701 Marinelli
Road, North Bethesda, MD 20852.
Contact Person: Mark Allen Vosvick, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3110,
Bethesda, MD 20892, 301–402–4128,
mark.vosvick@nih.gov.
Name of Committee: Biobehavioral and
Behavioral Processes Integrated Review
Group; Motor Function, Speech and
Rehabilitation Study Section.
Date: June 3–4, 2024.
Time: 9:00 a.m. to 7:00 p.m.
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[Federal Register Volume 89, Number 88 (Monday, May 6, 2024)]
[Notices]
[Page 37234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09727]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Amended
Notice of Meeting
Notice is hereby given of a change in the meeting of the National
Advisory Council on Alcohol Abuse and Alcoholism, May 7, 2024, 10:00
a.m. to May 8, 2024, 3:30 p.m., National Institutes of Health, National
Institute on Alcohol Abuse and Alcoholism, 6700B Rockledge Drive,
Conference Rooms A, B, & C, Bethesda, MD 20817 which was published in
the Federal Register on April 9, 2024, FR Doc. 2024-07500, 89 FR 24846.
This notice is being amended to replace the Contact Person from
Ranga V. Srinivas, Ph.D. to Philippe Marmillot, Ph.D. Director, Office
of Extramural Activities, Office of Extramural Activities, National
Institute on Alcohol Abuse and Alcoholism, National Institutes of
Health, 6700B Rockledge Drive, Room 2118, Bethesda, MD 20892, (301)
443-2861, [email protected]. Additionally, the meeting end time
on May 8, 2024, has changed from 3:30 p.m. to 3:45 p.m. The meeting on
May 7, 2024, is partially closed to the public in accordance with
provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5
U.S.C., as amended, and the meeting on May 8, 2024, is open to the
public.
Dated: April 30, 2024.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2024-09727 Filed 5-3-24; 8:45 am]
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